Indocin 50mg Capsules

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its primary mechanism of action is the inhibition of prostaglandin synthesis, mainly by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandins, which are mediators of inflammation, pain, and fever.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Allergic reactions: Rash, hives, itching, redness, swelling, blistering, or peeling skin with or without fever; wheezing; tightness in the chest or throat; difficulty breathing, swallowing, or speaking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood; coffee ground-like vomit; blood in the urine; black, red, or tarry stools; bleeding gums; abnormal vaginal bleeding; unexplained bruises or bruises that enlarge; or uncontrollable bleeding.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High potassium levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, fainting, numbness, tingling, or shortness of breath.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular concerns: Chest pain or pressure.
Neurological symptoms: Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Vision changes: Changes in eyesight.
Other symptoms: Ringing in the ears, depression, flu-like symptoms.
Liver problems: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be life-threatening and have occurred with similar medications.)
Severe skin reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical help if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in the mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following symptoms or any other unusual effects, contact your doctor or seek medical attention:

Headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
* Dizziness, drowsiness, fatigue, or weakness

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate drugs, such as aspirin, or NSAIDs.
Presence of certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack
Concurrent use of other NSAIDs, salicylate drugs (e.g., aspirin or diflunisal), triamterene, or pemetrexed
Fertility issues or ongoing fertility evaluation
Pregnancy, planned pregnancy, or suspected pregnancy. This medication may harm an unborn baby if taken after 20 weeks of gestation. If you are between 20 and 30 weeks pregnant, only take this medication under your doctor's guidance. Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. Verify that it is safe to take this medication with your existing medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Additionally, do not take this medication for a longer duration than recommended by your doctor.

Until you are aware of how this medication affects you, avoid driving and other activities that require alertness. Be cautious, as this medication may increase your risk of bleeding easily. To minimize this risk, use a soft toothbrush and an electric razor to reduce the likelihood of injury.

This medication may interfere with certain laboratory tests, so it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this medication. Before consuming alcohol, consult with your doctor to discuss any potential risks. If you smoke, talk to your doctor about the potential implications. Long-term use of this medication may require regular blood tests, so discuss this with your doctor.

There is a potential risk of developing high blood pressure with medications like this one. Ensure that your blood pressure is monitored as advised by your doctor. If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

The use of medications similar to this one has been associated with an increased risk of heart failure. If you already have heart failure, the risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor. Furthermore, people taking medications like this one after a recent heart attack have an increased risk of heart attack and heart-related death. In fact, individuals taking these medications after a first heart attack were more likely to die within the year following the heart attack compared to those not taking these medications. It is essential to discuss this with your doctor.

If you are taking aspirin to prevent a heart attack, consult with your doctor. In some cases, this medication has been known to worsen depression, mood problems, seizures, and conditions like Parkinson's disease. If you have any of these health issues and experience worsening symptoms, inform your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. It is also important to note that NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss this with your doctor if you are concerned about fertility.

Finally, if you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.

• Ketorolac (other NSAIDs)
• Aspirin (high dose, due to increased GI risk)
• Other NSAIDs (concurrent use increases risk of adverse effects)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Heparin) - increased bleeding risk
• Antiplatelet agents (e.g., Clopidogrel, Aspirin low dose) - increased bleeding risk
• SSRIs/SNRIs - increased GI bleeding risk
• Diuretics (e.g., Furosemide, Thiazides) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs - reduced antihypertensive effect, increased risk of renal impairment
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Cyclosporine - increased nephrotoxicity
• Digoxin - increased digoxin levels
• Phenytoin - increased phenytoin levels
• Pemetrexed - increased pemetrexed toxicity (renal impairment)

• Beta-blockers - reduced antihypertensive effect
• Corticosteroids - increased GI ulceration/bleeding risk
• Sulfonylureas - potential for increased hypoglycemic effect
• Quinolone antibiotics - increased risk of CNS stimulation/seizures
• Tacrolimus - increased nephrotoxicity

• Antacids - may delay absorption (not clinically significant)

• Signs of gastrointestinal bleeding (black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Signs of renal impairment (decreased urine output, swelling in ankles/feet, unusual fatigue)
• Signs of liver injury (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual fatigue)
• Signs of cardiovascular events (chest pain, shortness of breath, weakness on one side of body, slurred speech)
• Signs of allergic reaction (rash, itching, swelling of face/throat, difficulty breathing)
• Unusual weight gain or swelling (fluid retention)
• Changes in vision or hearing (rare, but reported with indomethacin)

Avoid use in the third trimester due to risk of premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension of the newborn. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Indomethacin is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., CNS effects, GI bleeding, renal effects), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness of oral indomethacin capsules have not been established in pediatric patients. The IV formulation is used for PDA in neonates under strict medical supervision.

Elderly patients are at greater risk for serious adverse reactions, including gastrointestinal bleeding, ulceration, perforation, and renal impairment. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects.

• Indomethacin is a potent NSAID, often reserved for conditions unresponsive to less potent NSAIDs due to its higher incidence of CNS and GI side effects.
• It is particularly effective for acute gouty arthritis and acute painful shoulder.
• Administer with food, milk, or antacids to minimize GI irritation.
• Patients should be advised to report any signs of GI bleeding (e.g., black, tarry stools) immediately.
• Monitor blood pressure, renal function, and liver function, especially in long-term therapy or high-risk patients.
• Avoid in patients with a history of aspirin-exacerbated respiratory disease (AERD) due to risk of severe bronchospasm.
• Due to its potential for CNS side effects (headache, dizziness, confusion), caution should be exercised when driving or operating machinery.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain/fever, no anti-inflammatory effect)
• Corticosteroids (for severe inflammation, short-term use)
• Colchicine (for acute gout)
• Allopurinol/Febuxostat (for chronic gout prophylaxis)
• Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions (e.g., Methotrexate, biologics)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.